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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Atrial Fibrillation Registry


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General
Study Status Progress Adequate
Application Number P030031 S011/ PAS002
Date Current Protocol Accepted 01/05/2018
Study Name OSB Lead-Atrial Fibrillation Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective, multicenter, non-randomized clinical evaluation of PAF patients treated with the radio frequency ablation with Thermocool catheters.
Study Population Description Study Population: Adult patients with paroxysmal atrial fibrillation (PAF).
Sample Size A minimum of 381 patients, 109 in the MEP group and 272 in the LEP group, enrolled at 40 sites. Since the endpoint is 7-day primary AE rate, it is anticipated that the attrition for this endpoint is minimum. In P030031/S085, it is indicated that a total of 407 subjects received RF ablation procedure with 125 in the MEP group and 282 in the LEP group. Of the 282 subjects in the LEP group, 76 remaining subjects who have not reached 5-year follow-up won’t be followed through 5 years.
Data Collection The primary safety endpoints include adverse events that occur within 7 days of an ablation procedure.
Follow-up Visits and Length of Follow-up Study participants will be followed for 5-years.


OSB Lead-Atrial Fibrillation Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 mth report 02/12/2010 02/12/2010 On Time
1 year report 08/13/2010 08/13/2010 On Time
18 mth report 02/14/2011 02/14/2011 On Time
2 year report 08/12/2011 08/12/2011 On Time
3 year report 08/13/2012 08/08/2012 On Time
4 year report 08/12/2013 08/13/2013 Overdue/Received
5 year report 08/12/2014 08/08/2014 On Time
6 year report 08/12/2015 08/05/2015 On Time
7 year report 08/05/2016 08/05/2016 On Time
8 year report 09/30/2017 09/29/2017 On Time
final report 04/06/2018    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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